BEUDAMED
    FDA Recall Terminated

    ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854

    Recall: Z-0548-2008 · Initiated November 19, 2007

    Recall

    Recall Number
    Z-0548-2008
    Event Number
    45809
    Firm
    International Technidyne Corporation
    FEI Number
    3005776351
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 19, 2007
    Posted
    January 25, 2008
    Terminated
    August 12, 2008
    Address
    20 Corporate Pl S, Piscataway, NJ, 08854-6144

    Description

    ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854

    Reason

    An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.

    Action

    ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.

    Distribution

    Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia.

    Quantity

    1,514 units